ID
32906
Beschrijving
Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form contains information about non-serious adverse events, occuring during the study. It should be filled in in case of drop-out due to non-serious AE.
Link
https://clinicaltrials.gov/ct2/show/NCT00241644
Trefwoorden
Versies (3)
- 01-11-18 01-11-18 -
- 17-11-18 17-11-18 -
- 19-11-18 19-11-18 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
19 november 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644
Non-serious AE
- StudyEvent: ODM
Beschrijving
Non-serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Non-serious Adverse Events Leading to Drop Out
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Non-serious Adverse Event Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beschrijving
Non-serious Adverse Event Description
Datatype
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1518404
Beschrijving
Date Non-serious Adverse Event Started
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0011008
Beschrijving
Adverse Event Started During Immediate Postvaccination Period
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0231291
- UMLS CUI [1,2]
- C1518404
Beschrijving
Date Adverse Event Stopped
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1518404
Beschrijving
Maximum Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1518404
Beschrijving
Relationship to investigational products
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1518404
Similar models
Non-serious AE
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])